廣東藥學院《藥學快訊》

/目錄TOC\*ＭＥＲGEFORMAＴ【醫(yī)藥進展】 PＡGEREF_Tｏc24２8６７2６2\h1美國FDＡ批準一種治療銀屑病新藥Sｔelara（ustekinumab) ＰAGEREF＿Ｔoｃ2428６７263\h１美國FDA批準第一種治療周圍T細胞淋巴瘤(PＴCL)新藥Foloｔyn（ｐralatreｘatｅ） PAGEＲEF＿Toc242８６7264＼h1美國FＤA批準Sabｒil用于嬰兒抽搐及癲癇發(fā)作 PAGEＲEF_Toc2４２867２６５\h２美國FDA批準Saphriｓ用于治療精神分裂癥與躁狂癥（雙相障礙）?PAGＥＲEＦ＿Ｔoc２４２867266\h3美國FDA批準一種新降膽固醇藥物Liｖalo（pitavastａt(yī)in） ＰAGＥREF＿Ｔｏc２42８67２６7\h4美國FDA批準一種治療II型糖尿病新藥Oｎｇlyza(saxａgliｐｔin） ４２86726８\h5美國批準秋水仙堿藥Ｃｏlcrys用于治療急性痛風和地中海熱 ＰＡGEREF_Toc24286７269＼ｈ6美國ＦDA批準200９-2010年季節(jié)性流感疫苗?７美國FDＡ批準阿片類鎮(zhèn)痛藥Onｓｏｌis用于癌癥患者 PAGＥRＥF_Toc2４２８６727１\h8美國FＤA批準Efｆient(ｐｒasugreｌ）片劑用于血管成形術病人 PＡGＥREＦ_Toc2４２867272\ｈ9美國FＤA批準第一種用于晚期或轉移性肺癌患者的維持治療藥物Ａlimta(pemetrexed) PＡGEＲEF_Toc242８67273\h1０美國ＦＤＡ批準Multａq（dronedａronｅ）片劑用于治療心率失常?PAＧEREＦ_Toc２4286７274＼h11美國FＤA批準一種通用名版緊急避孕處方藥用于17歲及以下少女 PAGＥREF_Toc2４2867２75\ｈ11美國FDＡ批準布洛芬（Ibupｒoｆen）注射劑Caldolｏr?PAGＥREF_Tｏc２42８6７276\h1２【政策法規(guī)】 PAＧEREF_Toc242８6７2７７＼h１39部門聯(lián)合發(fā)出通知要求加強食品添加劑監(jiān)督管理工作?ＰAＧＥREF_Ｔoc２42867278＼h13關于印發(fā)加強基本藥物質量監(jiān)督管理規(guī)定的通知 ＰAGEＲEF_Tｏc２4２86７27９\h13國家食品藥品監(jiān)督管理局要求暫停銷售使用標示為多多藥業(yè)有限公司雙黃連注射液?ＰAGEREＦ_Toc24２８6728０\h１5國家食品藥品監(jiān)督管理局要求加強甲型H1N1流感疫苗安全監(jiān)管工作 ＰＡGEREF＿Toｃ2４2８6728１\h15國家食品藥品監(jiān)督管理局印發(fā)含輔酶Q10和含大豆異黃酮保健食品產品注冊申報與審評有關規(guī)定?ＰＡGＥＲＥＦ_Toc２42867２8２\h15藥品不良反應信息通報（第２3期）?３\h16國家食品藥品監(jiān)督管理局修訂溴隱亭和二氫麥角隱亭制劑說明書?PＡGERＥF_Toｃ２4２８6728４\h１8國家食品藥品監(jiān)督管理局關于印發(fā)藥品技術轉讓注冊管理規(guī)定的通知 PAGEREＦ_Tｏｃ242８672８5\ｈ１８國家食品藥品監(jiān)督管理局啟動流感防控藥械督查工作對甲型H1N1流感防控藥械生產、經營、儲備、使用環(huán)節(jié)進行核查?PAGERＥF＿Toc２４２8６７286\h19【業(yè)界新聞】?PAGEREＦ＿Ｔoc2428672８7\h202008年度ＳFDA藥監(jiān)統(tǒng)計年報?PＡＧEREF_Toc２4286728８＼h20國家基本藥物制度工作正式啟動?PAＧEＲEF_Toｃ2４２867２89\h2１我國藥品注冊管理出現(xiàn)新變化?ＰAＧEREF＿Toc242８６7２90\h2２2009年9月美國FDA藥品審批情況一覽表（本月數(shù)據截至9月24日)?PＡGＥＲＥＦ_Ｔoc24２867291＼ｈ2５20０９年8月美國FDＡ藥品審批情況一覽表 PAGＥRＥＦ_Ｔoc242867２92＼ｈ31國家藥物安全評價監(jiān)測中心率先接受美國ＦDAＧＬＰ檢查 PＡGEREF_Toｃ２428６７２9３\h36中國藥品行政保護?PＡＧEＲEF_Ｔoｃ２42867294\h3６【國外知名藥企動態(tài)】 ＰAGEＲＥF_Ｔoc2428６７2９5\h38ＲesuｌｔsReporｔedfｏrEｘploratoryPhaｓeIITrialofNexａvarｉｎCombiｎａt(yī)ioｎｗｉthCｈemｏｔｈeｒaｐｅutiｃAｇentＰaclｉｔaxelforＴrｅaｔmｅｎtofAdｖancｅdBｒeasｔCａnｃer PAGEREＦ_Toc２42867296\h３８葛蘭素史克完成對Ｓtｉefel的并購?ＰAGＥRＥＦ_Ｔoｃ２４2８６7２97＼h38流感大流行（Ｈ1N1）2009最新消息:來自ＧSK的關于Ｈ1N1佐劑疫苗第一項臨床試驗的初步結果 PＡＧＥREF_Toc２4２８67298\h39ＢSI－2０1治療轉移性三陰乳腺癌進入IＩI期臨床?PAGERＥF_Toc２４2８672９9\ｈ４0一年給藥一次的創(chuàng)新藥物密固達有效提高絕經后骨質疏松患者對藥物治療的依從性，全面提升骨密度,降低骨質疏松骨折風險 ＰＡGEREF＿Toｃ2428６7300\h4１MerｃkKGａAＳubｍitsAｐplｉcationｆorClａdｒibineTａｂleｔsａsMultｉpleScleroｓｉsTheraｐyinEurope?PAGEＲEF_Toc２42867301\h４2SecondPhaseIIIＳtuｄｙShoｗeｄLｕcentiｓImpｒoｖedViｓiｏnｉnＰaｔientｓwithRetinａｌVｅinOcｃlｕsiｏn?PAGEREF_Toｃ242８67302\h４３【專題】?PAGEＲＥF_Toc242８67303\h４３美國FＤA批準4種H1N1流感病毒疫苗?PAＧEREF_Toc２4286730４\h43新華網：美國正式批準4種甲型流感疫苗上市?PAＧERＥF_Tｏc２4２86７305\ｈ44國外有關研究顯示:甲型H1N1流感病毒傳染期或長達一周 ＰAGEREＦ_Toc２42867３06\h４5國家食品藥品監(jiān)管局批準華蘭公司甲型H1Ｎ1流感疫苗注冊申請?PAＧEREF_Ｔoc24２867307＼h45國家食品藥品監(jiān)督管理局批準北京科興甲型H1N1流感疫苗注冊申請 ＰAＧEREF＿Tｏc24２８67308\ｈ4５美國FDＡ提醒公眾警惕網上有關出售抗H1Ｎ1流感產品的虛假信息 PAＧERＥＦ＿Toc2428673０9\h47圖書館關于定向信息咨詢師調整的通知?ＰAＧEREF_Toc24286７31０\h４8【醫(yī)藥進展】美國ＦDA批準一種治療銀屑病新藥Sｔelａra（ustekiｎｕｍab）FDＡAｐprovｅｓNeｗDruｇｔｏTｒeatPsoriａsｉｓ（Sept．25，20０9）ＴheU.S.FooｄandDrｕgAdministraｔionｔodａyapproｖedＳteｌara（ｕstｅkｉnumab）,abiologicｐroduｃtｆoｒａｄuｌtswhohaveamoｄeｒａt(yī)etｏseｖereformofpsorｉａsis。Plaｑuepｓｏriasiｓisanimmuneｓysteｍdｉｓｏrdeｒｔhatrｅｓuｌｔsintｈeｒapidoveｒprｏduｃtionｏfｓkiｎｃells．Aboｕｔ6milliｏnpeopleintｈeUｎiteｄSｔateｓhａvepｌaquｅpsorｉasiswｈichisｃｈaｒacterizeｄｂythickenedpatchesｏｆｉｎflaｍed，rｅdsｋｉn，oｆｔencovereｄwｉthsilvｅryscａｌes.“Thisappｒovalｐroｖｉｄesａnalternaｔivetｒeatmeｎｔforｐeoplewiｔhplaquｅpsoriaｓis，whｉchｃancausｅsｉgｎiｆicａｎtｐｈysｉcaｌdｉｓcｏmfoｒtｆrompａinanditｃｈingandｒｅsuｌtｉnpoorｓelf-ｉmaｇeforｐeoplewhoareｓelf－ｃoｎscｉoｕｓaboutthｅｉrapｐeａranｃe,”saidJulieBeｉtｚ,M。D．，dｉrｅctｏｒ,OfficeofDrugEｖalｕatｉｏnＩII,inｔheＦDＡ'sCeｎterforDruｇEvaluaｔｉoｎａnｄResｅarch.Stelaｒａｉsamonoclonａlanｔｉｂody,ａlａbｏｒａt(yī)ory—producedmolecｕlｅthatmiｍiｃｓtｈeｂoｄy'soｗnanｔibodiｅｓthataｒepｒoducedaspartoｆtheiｍmunesystem．Thebiologiｃtrｅatｓpsoｒiasｉsbyblｏｃkingthｅａctionｏftwｏｐｒoｔｅｉnsｗhichｃontrｉbutｅtotｈeoｖerproducｔiｏｎoｆskincｅllsandinｆlammatｉon。Thrｅｅｓtudieｓoｆ２，２66patientｓevａｌuatedｔhebiologｉc’ssafｅtyaｎdｅfｆｅｃtiveneｓs.SinｃｅStelarａreduｃesthｅimmunesyｓtem’sabｉlitytofighｔinfｅctions,tｈeｐrｏductposｅｓariskofinfection。Sｅriousinfｅctioｎshavebeenｒeportｅdinpａt(yī)ienｔsｒeceiｖingｔheproｄｕctaｎdsomeofthemhaｖeleａｄtoｈospitalizatioｎ。Ｔｈeseiｎｆｅcｔｉonsweｒecａusedｂyvｉruseｓ，fungi，ｏrｂaｃtｅrｉａt(yī)hatｈavespreadtｈrouｇhoutthebody.Theｒemayaｌsｏbeaｎincrｅasedriskｏfdevelｏpｉｎｇcancer．TｈｅFDAisrequiｒｉnｇariｓkｅvaluatiｏnandmｉtｉgatiｏnstｒategyorＲEMSｆorSteｌａrathaｔｉnｃlｕdeｓacommuｎicationpｌanｔaｒｇetedtｏheaｌthcａreprｏviderｓandameｄicａt(yī)ionｇuideforpatients.SｔelａraismａnufａcturedbyＣentｏcｏrOrtｈoBiotechInc。ofHoｒｓham，Pａ。，aｗholly－ownedsubsiｄｉarｙｏfJohnsoｎ＆JｏhnsｏnｏｆNeｗBrｕnswicｋ(）美國FDA批準第一種治療周圍Ｔ細胞淋巴瘤（ＰTCL)新藥Ｆoloｔｙn(pｒａlａt(yī)reｘate)ＦDＡApｐｒoveｓFｉｒsｔＤrugｆorTｒｅatmentofPｅrｉpheralT—ｃeｌlLymｐｈｏma（Sｅpt。25，2009）ＴheU.S．FoodandDrｕgＡdｍｉnisｔｒatｉｏnｈａｓapｐrovｅdFoloｔyn(praｌatrexate),thefｉｒｓttreatmｅｎtｆoｒaformｏfcａｎceｒknownaｓPeriphｅralT—ceｌlLyｍｐhoｍa(PＴCL），anoｆtｅnagｇｒｅssiｖｅｔyｐeofnoｎ—Hodｇkiｎslymphoｍa。ＦｏlｏtyｎwａsapproveｄｕndｅrｔheFＤＡ’saccｅlｅrａt(yī)ｅｄａcｅsｓ，ｗhichａlｌoｗseａｒｌierａpprovａlｏfdｒuｇstｈaｔmｅetｕnmetmeｄicalneｅds.Ｉtisappｒoveｄｆorpatｉｅntsｗhohaverｅｌapｓed,oｒhａvenotrespｏndedｗelltｏｏｔｈerforｍsoｆcheｍoｔheraｐy.Ｌymphｏmaiｓacancerofｔｈelympｈaｔicｓysｔem，whｉchisｐarｔoftｈeimmunｅsystem．Tｈerｅaremanyｔｙｐesoｆlymｐhoma：ｏnｅtｙpｅiscalleｄHodgｋiｎ’sｄiseaｓe,ａｎdtheｒeｓtarｅcａlｌednｏn-Hｏdgkin'ｓｌｙmphomas．PTCＬｉnvｏｌｖesａt(yī)ypｅoｆwｈｉteｂｌｏodcｅllcalledT－cｅlｌs.Ｉtisarｅlativeｌyrarediseasｅ,occurringinlessｔhan9，500ｐａｔｉｅntseachyearｉnｔｈeＵｎitedＳtatｅs.“Ｆｏlｏtyn'sapprovａlｄｅmonstratｅｓＦDA＇scomｍitｍｅｎｔtｏtherａpidａｐprovalofｄrugsforｒａreａnｄｕncｏmmｏｎｄiｓeasｅs，”saiｄRicｈaｒdPaｚdur，M。D。,direcｔoroｆtheOffｉceｏｆOncoｌogyDｒugProｄucｔsintheＦDA'sＣenterfｏｒＤruｇEvaｌuationanｄResearcｈ。Ｗhensｔudｙｉnganewｄrｕg,ｉtcantａkｅtｉｍｅtｏlearnwhetheradrugacｔuａllypｒoｖｉdesreａｌimprovementｆｏrpatientｓ–suchａsｌivingloｎgｅｒoｒfeeｌinｇbetｔeｒ。Thｉｓreaｌimpｒｏvｅmｅｎｔｉｓknownａsa“cliｎｉcａlｏuｔｃomｅ．”In1992FDAｉｎstitutedacceleratedapproｖａlｓｗｈichallowearｌieｒａppｒovaｌofdｒugｓbasｅdonasｕrrｏｇatｅendpoｉｎｔ，alａboratorymeasurementorphyｓicalsigｎｔｈatcａnｓerveasanｉｎdirectorsｕbsｔituｔｅmeasuｒeｍeｎtｆｏｒclinｉｃaloutcomｅs.InthｅcaseofFoloｔｙn，thｉsmeantｔｈeFDAａpproｖedthedrugbaｓedｏnevｉdenｃｅｔｈatｉtreｄuceｓtumｏrsiｚe,bｅcausetｕｍorｓhrinkａｇeisconsiderｅdreasonａblylikelytopｒｅdictａcliｎｉcalbeｎefitsuchasｅxtendｉｎgthesuｒvivalｏfcancｅｒpａｔiｅnｔs.Tumoｒshrinkａgｅwａsseenｏｎiｍagiｎgscａnsinonesｔｕdy。Of10９paｔientswｉthPTCＬｉｎtheｔriaｌ，27%hadreｄucｔｉｏnintumoｒｓｉze．Tospeｅdtheｄrｕg'savailａｂility,Ｆolotynwasgrantedprioｒityｒeｖiew，enｓurinｇareｖiewwithinsiｘｍonｔhｓraｔherｔｈan10monthｓforａstａnｄarｄｒeｖiew.Thedrugwasalsｏｄesiｇnatｅdasanｏrｐhandrug,ｗhｉcｈprovideｓavａriｅtyofｆinanｃialinｃentiveｓtomａnｕfａcturersｔhatｄｅveｌoｐdrugsforasmalｌnuｍｂerofｐatienｔｓwithａrarｅdisorｄer.TｈｅmoｓｔｃｏmmonaｄvｅrsｅreactiｏnｓseenｗｉthＦolotynwereirｒitationorsoｒeｓoftｈemuｃousmembrａｎeｓｓuchastheｌiｐs，thｅmｏuｔh,andtｈedigeｓｔivetｒａct,lｏｗplatelｅtcellcｏｕntｓ,lowwhｉｔｅbloodcｅｌlcoｕｎts,ｆever,nausｅa，anｄfａｔigue。Ｆolotyncanharmａｆetus。Woｍｅｎshoｕldavoiｄｂecomiｎgpｒegｎａntwhilebｅiｎgtreatedwiｔhthｉsdrugａｎdｐrｅｇnａntwomeｎsｈoulｄbeinｆormｅdofthepoteｎｔialriｓk.PaｔｉenｔstreatedｗithFｏlotynshouｌdtａkefｏlａt(yī)ｅandvitamｉｎB1２ｓupplｅmenｔｓtｏredｕcemucoｕsmeｍbraneirritａｔiｏn.FolotynismanｕfacturedbyＡｌlosTherａpｅuticｓInc.oｆWesｔｍｉｎsterAsaconditioｎofａcｃelｅratedappｒｏvaｌ,Allｏswilｌｃｏnｄｕcｔstuｄiｅstｏｃonfｉｒmthａt(yī)tuｍorsｈrinkaｇeactuallydoesｐredictｔhａt(yī)patｉentswiｌllｉvｅlongeｒ.(）美國FDA批準Sabriｌ用于嬰兒抽搐及癲癇發(fā)作SａｂrｉlＡpproｖeｄbyＦDAtoTreaｔSｐａsmsinInｆａｎｔsａnｄEｐilepticＳeizuｒes（Aug.21,2009）Ｓabril（vigａｂatrｉn）OralSｏｌutionhasbeenappｒovedｂｙtheU。S。FｏｏdandDrｕgAdminisｔratioｎｔoｔreatiｎfａntｉｌespasｍsinchｉｌdｒeｎａges1monthtｏ2years.SabrilｉsthefiｒsｔdruｇinｔheＵnitｅdStateｓappｒovedtotreatｔhedisoｒdｅr,chａraｃteｒｉzedbｙaseｖerｅtypeｏfseizurethatuｓuａllyａppｅarｓinthｅfｉrstｙｅarｏfｌｉfｅ,ｔyｐiｃａllyｂｅtｗｅenａgｅs4monｔhsand8mｏnｔhｓ.Theｄisordercaｎｂeｄeｂiｌｉtaｔｉｎgｂecauseｏftheｆｒequencyoｆdiｆｆiculｔ－tｏ-ｃoｎtroldaｉlｙseizuｒes。Sabrｉｌ（ｖigaｂatrｉｎ)Tabｌetsｈaveｂｅｅnａpｐｒｏvedforaｄultｕseincombinationwitｈotｈｅｒmedｉcaｔionｓｔotｒｅatcoｍplｅxpaｒtialseiｚｕresthathaｖeｎoｔｒespoｎｄｅdａdequaｔｅlyｔopreviｏuｓｄrugtherapiｅｓ．“Ｓeizｕｒesｃancauseimpａiｒeｄnｅｒｖｏussystemfuｎctｉｏnandｒeｄucｅdqualiｔyoflｉfe，"saｉdＲｕsseｌｌKatz，M．D.，direｃｔorｏftheDivisionofＮｅｕｒolｏgyＰrｏductｓａt(yī)theＦDＡ’sCeｎterfoｒＤruｇEvaluationａndResearch.“Infａｎtilespasmsinｃhildrenｔhisｙoungaｒeveryseｒiousanｄthiｓaｐpｒovａｌｐroｖｉdesthesｅpａt(yī)ientｓandｔｈeirparentｓatｒeatmｅntoptｉon．”Inｆantilｅspasmscoｎｓｉstｐrimarilｙofasuｄｄenbｅndingfｏｒｗａrdoｆthｅｂodywithstiffeniｎｇoｆtheａrmsanｄlegs；ｓomechｉlｄrｅnarchtheiｒbackｓastｈeyextendtｈeiｒaｒmsａｎdlegs.Ｓｐａsmsｔeｎｄtoｏccuruponawakeningｏrafterfｅedｉng，andｏftenoccuｒinclustersofupto10０spasｍs。Ｉnｆaｎtｓmayhavedozenｓofｃｌusterｓanｄsｅｖｅralｈundredspasmspｅrdａy．Manｙundｅrｌｙiｎｇdisoｒdｅｒｓ，sｕｃhasｂirｔｈiｎjuｒy，metａbｏlｉcdｉsoｒdeｒs,anｄgenｅticdisoｒdeｒsｃａngiveｒisｅtospasｍs,mａkiｎｇitiｍpoｒtaｎttoｉdeｎtiｆytｈeｕndｅrｌyingcaｕsｅ。Inｓoｍechildreｎ,nocauｓecanbefound．Eｐｉlepsyisaneurｏloｇｉcalcondiｔｉonthatprodｕcesｄistｕrbancesiｎｔheｎoｒｍａlelectｒicaｌfunｃtiｏnsｏｆthebｒａｉn，causingpeopletohaｖereｃuｒringsｅｉｚurｅs.Seｉzureshａppｅnwhenneｒｖecells,orneｕronｓ,iｎthｅbrａinsendｏuｔｔｈeｗｒongｓigｎａlｓ.Pｅoplemayhａvestrａngｅｓeｎsaｔｉｏnsａnｄemotｉonsorｂehaｖeｓtrａngｅly。Tｈeyｍayhaｖeviolｅntｍusｃｌejerkiｎｇ,whichmayｂerepetitive，orｌoseconｓｃｉousｎess。DamａｇetｏvisionｉｓanimporｔantｓafｅtyconcernwitｈtheuseｏｆSａｂriｌ。Thedrugｗillhavｅａboxedｗarniｎgtoalertｈｅaｌthcareｐrofessioｎalｓtothiｓriskoｆaｐrogressivelossｏｆpeｒｉpheralvｉｓionwithpoｔentialｄeｃreaseｉnｖisuａlａcuiｔy。Theｒisｋofvisionｄaｍagｅmａyｉｎcreaｓｅbａｓedonｔhｅdosageanｄｄurａt(yī)ionoｆｕsｅ,butevｅnｔhelowestｄｏsesofSabrｉlcancaｕｓevｉsｉｏndamaｇe.PｅｒiｏdicvｉsiontestｉngiｓreｑuirｅdｆｏrthｏsｅtａkingSａｂriｌ．Becauseoｆｔherisｋoｆｐeｒmａnentｖiｓｉｏｎｄamage，thedｒugｗillbeavaｉlａbleoｎlyｔhｒouｇｈａrestriｃｔeddiｓｔributioｎpｒoｇram.Sａbriｌwasdesｉgnａt(yī)ｅdasａnorphaｎｄｒugbytｈｅFDAfｏｒuｓｅｉｎｔreaｔｉnｇinｆａｎｔilesｐａsms.Adrugiｓｅliｇibleforoｒphandrugｄeｓｉgnatioｎiｆiｔisiｎtendedtotreａｔadiseａseｏｒconｄitiｏnthａｔafｆectｓｌessthan200，０0０peopleｉｎtheUnｉｔedStates.Oｒphａndrugstatuｓproviｄｅsthecoｍpａnywｉthｆｉnanciaｌincentｉvestｏpromｏtethedeｖelopｍeｎtoｆadruｇtoｔrｅatａrarediｓｅasｅorcｏｎdｉtion.SabrilisｍadebｙＬｕndbｅｃkInc．of，Deerfielｄ()美國FＤA批準Saphris用于治療精神分裂癥與躁狂癥（雙相障礙)FDAApprovesSaｐhristoTrｅatＳchizoｐhrｅnｉaａndBipolaｒDisorｄer(Aug。14，20０9）ＴheU.Ｓ．FoｏdａnｄDruｇＡｄmｉnistｒaｔionhasapproveｄSaｐhristablｅｔs(aｓｅnaｐine)ｔoｔreaｔaｄｕltsｗithschizoｐhｒenｉa,ａchｒonｉｃ，severeaｎddiｓaｂlingbrａｉnｄisordｅr,aｎdｔotreatbｉpolarIｄｉsorｄeｒｉnaduｌts，ａｓerｉouｓpsychｉatricdiｓorderｔhatcａusesshifｔsiｎaｐｅｒson'sｍｏod,energy，aｎdａbilitｙtofuｎctiｏn.“Ｍeｎtalillnｅｓｓeslikeｓchｉzｏphrｅniaanｄｂipｏlaｒｄｉｓoｒdercanｂedevastａt(yī)ingtopａt(yī)ｉentsａndfaｍiｌiｅs，reｑｕirｉnglifeloｎｇtｒeatmentａｎdtheｒaｐｙ，”ｓaidThomasLauｇhren，Ｍ.Ｄ.，diｒectoｒoftheDiｖiｓionofPsycｈiａt(yī)rｙＰroduｃtsｉnｔheFDＡ’sCenterfｏｒDrugEvaluatioｎaｎdResearch.“Ｅｆｆeｃtiveｍｅdｉcinesｃanhｅｌppeopｌewithmenｔalillnesｓlivemｏreindｅｐendentｌｉves.”Ｔheｍosｔcoｍmoｎsymｐtoｍsofschｉzophｒeniaiｎcludehearinｇvoiｃeｓ，ｏｒseeｉngtｈiｎgsthａt(yī)arｅnｏttherｅ，havingfaｌsebｅlｉｅfｓ(forｅｘａｍｐle,belｉevinｇｔhatotheｒsarecoｎtｒollinｇｔｈoｕｇhｔs,readingmｉnds，ｏrplｏtｔiｎｇｈａｒm），aｎdbeinginappｒｏpriatｅlysuspiciousorpaｒａnoid。Thｅｓeｔhoｕghｔｓmayｂeterrifyｉnｇａｎdcanｃauｓefearfulneｓｓ，witｈdｒawａl，agitatｉｏnｏrviｏlenｃｅ。BipoｌaｒIdｉｓoｒdｅｒｉsａchrｏnｉc，sｅｖere,aｎdreｃurrentpsycｈｉatricdisorderthatcaｕsesａltｅrnaｔingperｉodsofdepressiｏｎandhigh,incｒeasｅdａｃtiｖｉｔyanｄｒesｔlessness,ｒacingthoughts，talkiｎgfasｔ，impuｌｓivebehaviｏr，andaｄecreａsｅdneeｄforｓleｅｐ.Saphrisisｉnａｃlassｏfdrugscalｌｅdatypｉcaｌantｉpsychoticｓ.Allatyｐiｃａlａntipsychotｉcscontａｉnaboｘedｗaｒning，ｔhｅFＤＡ’ｓｓtrongｅstｗarｎing．Thewarninｇalｅrtsｐreｓcribersｔoaｎincrｅasedｒｉsｋｏfdeathassｏciａｔｅdwitｈoff-labelｕseoftheseｄrugstotreatbehａvｉoraｌpｒoblｅmsiｎolｄerpｅｏpｌewithdeｍeｎtia－rｅlａt(yī)edpｓyｃhosis(ａbｒａindｉsorｄerthaｔlesｓｅnstｈeabilitｙｔorememｂeｒ，thiｎk，aｎdreasｏｎ).Ｓaphｒisisnotaｐprovedｆorｔheｓｅpａｔientｓ.ThｅeffｉcａcｙofSａphrｉsｉｎtrｅatiｎgscｈiｚophreniaｗasstｕdiedintｈreeshort－termplａcebｏ-controｌlｅdanｄactivｅ—dｒugcontrolleｄclｉnｉcaltｒials．ＩntwｏofthetｒｉalsSapｈrｉｓdｅmonstraｔｅdsuperioreｆficacycｏmparedｔoaｎinａｃｔivepilｌ（plaｃebo）inredｕcingthesymptｏmsｏfｓchizoｐｈrenｉａ.ThｅefｆｉcａcyofSaｐｈrｉsiｎthetrｅａt(yī)ｍentofｂiｐolａrｄisoｒｄerwasstｕdiedintwoshoｒt－tｅrｍplacebo—conｔｒollｅdandacｔive-drugcｏnｔrolｌedcliｎiｃaltriaｌｓｉnwhichＳaphｒiswasｓｈｏｗntｏbｅsupeｒiｏrtoｐlａcebｏintｒeatingｓｙmptｏｍsofbipolardisorder.Ｔhemostcｏｍmonaｄｖersｅrｅacｔioｎsｒeporｔｅdbｙpatiｅntsiｎcliniｃａltrialｓbeiｎgｔreａt(yī)edｆorｓchizｏphrｅniawiｔhSaｐhrｉｓweretｈeinａbｉｌitytｏsitstiｌlorrｅmaｉnmotionless(akａt(yī)hisｉａ)，dｅcrｅａsｅｄoｒalsenｓiｔiｖitｙ(oralhypoesthｅsia）anｄdrowsinｅsｓ（somnolence).ThemostcomｍonadｖersｅrｅaｃtｉoｎｓｒeporteｄbyｐatienｔsinclｉnicaltｒｉaｌsusｉnｇＳaｐhrisｔotreaｔbiｐｏlaｒdisorｄerｗｅrｅdｒowsinｅsｓ，dizzinｅｓｓ，mｏｖｅmeｎｔdisorderｓｏｔｈerthaｎａkathisiaａndweiｇhtｉncrｅａse.SaphｒisiｓmａnuｆacｔuredｂySchering—Plough，Kenｉlworｔｈ（）美國ＦDA批準一種新降膽固醇藥物Ｌiｖalo(pitavａstatin)FＤAApｐrovesNｅwＣholesterol—ＬoweringDruｇ（Auｇust3，2009）TｈeU。S.ＦoodanｄＤruｇＡdｍinｉｓtrationtoｄayappｒovｅdtｈe4mｉlligrammaximuｍｄosｅofLｉvaｌo(pitavastａt(yī)in）,ａｄrｕgintｅndedtoimpｒoｖｅbloodcholｅstｅrｏllｅｖelsiｎpersonswiｔhelevatedｏｒabnormａlbloｏdcｈoｌｅsteｒollｅvｅls.Liｋeothｅrsｔatins,Livａｌendedｆorpａt(yī)iｅｎtswhendietandexeｒciｓefailtolｏｗｅｒtｈeircholestｅｒolleｖels。ＳtaｔinsimprｏｖｅeleｖaｔedｂloodｃｈoｌesterollｅveｌｓprimarｉｌｙｂyｉnhibiｔingalｉvｅrenｚyｍｅcalledHMＧCo—Arｅducｔａse,tｈｕsreducinｇtheliver＇saｂilitｙtomakｅchoｌestｅｒol.＂Elevaｔedorａbnoｒmalｃholesterollevelsareaｓsociatedwiｔhａniｎｃreaｓedrisｋforheartdiseaseandｓｔｒoke,”saｉdＥriｃC。Coｌman，Ｍ．D.,deｐｕtｙdireｃtｏr,DivisｉonofMetaboｌismandEndoｃrinolｏgyＰroｄuctｓ，iｎｔhｅFDA’sCｅｎteｒforDｒugEvａluatｉonanｄRｅsｅarcｈ?！埃裕飀ay’sapprovalｏfferspａt(yī)ｉｅntsａndｔheiｒhｅａltｈcareprofｅssiｏｎａlsanｏｔｈeraltｅｒnatｉvewaytotreaｔhiｇhchoｌesterol。"Livaloｗasａpｐrｏveｄonｔhｅbａsiｓofｆｉveclｉnicaｌtrialscomｐarinｇitsｅfficacyａnｄsafetytothatofｔhｒeeｃurrentｌｙmaｒketｅdｓtatinｓ。TｈemosｔfreｑｕｅｎｔlyreporｔedadｖｅｒsereactiｏnsfroｍtakingＬivａloweremusｃｌepain,baｃｋpaｉn，jｏｉnｔpａinaｎdconstipation。ＬivaloismanｕfacｔuredbyＫowaPhaｒｍaceuｔｉcａlsAmeriｃaIｎc.ofMontgomerｙ（）美國FＤA批準一種治療IＩ型糖尿病新藥Ｏｎｇlyｚa(saxagｌiｐｔin）FＤＡＡppｒｏvｅｓNewDruｇTｒeaｔｍｅｎtfｏrTypｅ２Diabeteｓ(Juｌy３1，2０09）TheU。S.FｏodandDrugAｄｍinisｔrationtｏdayaｐprｏvｅdＯnglyza（saxagliｐtin），aｏnｃe-ｄaｉlytabｌeｔtｏｔrｅatＴyｐe2diaｂetｅsinadults.Theｍedｉcatiｏniｓｉntｅｎdeｄｔｏbeuｓedwithdietanｄexercisｅtocontｒｏｌhiｇhｂｌoｏｄｓugarlevels．Tｈehｏrmonｅinsulinkeｅｐsbloｏｄsugａr（glucose）levelswiｔhinanarｒowrａngｅｉｎpeoplewhｏdon’tｈavｅdiaｂeｔes.ＰeｏpｌeｗithType2diabetesａreｅｉｔherｒｅsisｔanｔｔｏｉnsuｌｉnordoｎoｔproｄuｃeｅｎougｈinｓｕlintomainｔaｉnｎｏrmａlblｏｏdsugaｒlｅvｅlｓ.Ｏｎglyzａisinaｃlａssofdrｕgsｋnownasｄiｐｅptiｄylpeptidase-４（ＤＰP-4)iｎhｉbｉｔｏrswhiｃhstiｍuｌaｔethｅｐancreastomakｅmoreinｓulinafterｅatinｇaｍeaｌ?！埃薳ｅpinｇbｌooｄsugaｒｌevｅlｓｉｎadｅquatｅcoｎtroliｓessenｔialtothegoｏdhｅalｔhoｆtｈｅ24millｉｏｎｐeｏpleｉnthｅUｎitedStateswｉthTyｐe２ｄｉabeteｓ，”saidMaryPaｒks,Ｍ.D.，directｏrｏfthｅDivｉｓｉonoｆMetabｏlismaｎdＥndｏcriｎｏlogyProductsiｎtheFDA’ｓＣenterforDruｇEvaｌuatiｏnaｎdＲeｓearｃh?！癏ighｂlooｄsugarｌｅveｌscａｎcausｅbｌurｒｙvisｉｏnaｎdexcessiｖeuｒｉnationandevenｔualｌｙresultｉnsuｃhsｅriousconｄｉtiｏｎsaskiｄneｙａndeyｅdiseaｓe．”ＴhｅmoｓtcｏmmonsideeffeｃｔｓｏｂserｖｅdwithＯnglyzaaｒeuｐperresｐiｒaｔorｙtractinfectｉon,ｕrｉnarytractinｆeｃtｉｏn,andheａｄａｃｈe。Otherｓｉdeeｆfectｓincluｄｅaｌleｒgic-ｌｉｋerｅａctionｓｓｕchａsｒaｓhａnｄhｉｖes.ApproｖalofＯnglｙzaｗasｐriｍａｒilybasedｏnｔhｅrｅsultsofeiｇｈtclinｉcａｌtrials.ThｅapplicaｔionsｅeｋｉｎgＦＤＡapproｖａlwassubmitｔedbｅfoｒｅDeceｍｂｅｒ2０0８whentｈｅａｇencｙrecomｍeｎdｅdthaｔmanufacturersofnewdiabetesdrｕgscareｆullydｅsignaｎｄevalｕatｅtheiｒｃlinicａltrialsforcａrdiovasculａrsafeｔｙ。ＡｌthｏuｇhOnｇlyzａwasnoｔaｓsociａt(yī)ｅdwｉthａｎinｃreasedrｉskｆｏrcａrdiovasculａreventｓinpaｔiｅntsｗhowerｅmaiｎｌｙatlｏwrisｋfortheseｅvents，tｈeＦＤAisreｑuｉrinｇapostmaｒketstudythatwillｓpｅcifiｃallyevalｕatecａrｄiovascｕlaｒsａｆeｔyｉnaｈｉｇｈerｒｉsｋpopuｌation.OnｇlyzaismanufacｔｕｒedbyBriｓｔoｌ—MyersSｑuiｂbCo.oｆPrｉｎceton,N．J．，ａndmarkeｔedbyBｒisｔol-MyeｒsandAｓtrａZenecaPhａrｍaceuｔicalｓLP,ofWｉｌmingtoｎ（）美國批準秋水仙堿藥Coｌcｒys用于治療急性痛風和地中海熱FDAAｐprovesＣolchｉcinｅforAcutｅＧｏuｔ,ＭediｔerraneanFeｖer（Jｕly30，20０9）Aｇencyalsoprovidｅsneｗinｆormatioｎtoｐhｙsiｃiansreｇａrｄｉngsafeuseｏｆｄｒug。TｈeU。Ｓ.FoodandDrugAdmｉｎｉsｔrａt(yī)ionhaｓappｒoｖedColcrystｏtreatacutｅflairsinpaｔiｅntswitｈｇouｔ,arｅcuｒrenｔandｐａinfulforｍoｆarthritis，andpaｔienｔswｉthfaｍiliaｌMediｔeｒｒaneanfever(FMF)，aniｎｈeritedinflammatｏrydiｓoｒder．Tｈeｍeｄicaｔion'saｃtｉveingreｄｉenｔｉsｃolchicine,ａcｏmplexcomｐounｄderiｖedfｒomthｅdrieｄseｅdｓofaplantkｎownａstheautumnｃroｃusormeadｏwsａfｆron（Colchicｕmａutuｍnale)．ColchicineｈasbeenｕsedbyｈeａlｔhcarepractｉtionｅｒｓｆｏrmanyｙearsｔotｒｅatgoutbuthaｄnotbeeｎａｐprovedbyｔhｅFDA.ＴｈｅFＤAｈasaninｉtiａt(yī)ｉvｅundｅｒwayｔobrｉngunapｐrｏved，ｍａrkｅductsliｋecolchｉｃineuｎｄｅｒitｓregulatoryｆraｍeworｋ．Thｉsiｎｉtｉaｔivepromｏｔesthegoaｌofasｓuｒinｇｔｈatａllｍａrkeｔeddrｕgｓｍeeｔmodernｓtaｎｄarｄｓｆorｓafｅtｙ，eｆfectiveｎesｓ，qｕalityａndlabeling．Ｐｈｙsiｃiａnshisｔorｉcａlｌyｈaveｇivenｃolchｉcinｅｈｏuｒlyｆoｒａcｕtｅgoutｆlaresuntｉlthefｌaresｕbsideｄortheｙhadtｏstｏptｒeatmenｔｂecausethepaｔientbｅganexperｉencｉnggastrｏiｎｔｅｓtinalprｏｂlems。AdｏｓｉngｓtudyrequｉｒedaspaｒtoｆFDAapｐｒｏvaldeｍonstratｅdｔhatｏnedoseinitiａllyandaｓｉnｇleａdditionａｌdoseafteroｎeｈourwaｓjusｔaｓｅｆfecｔiｖeascoｎtiｎuedhoｕrlydoｓｉngforａcutegoutflaｒｅs,ｂutｍuchlesｓtoxic.Ａsaｒesuｌt，thedrugisbeinｇａpｐｒovｅｄfｏｒacutegｏutｆlarｅswiｔhthｅlowｅrｒecommendeｄdosingｒeｇiｍen。ＴｈeFＤＡisａlertｉnｇheaｌｔhcareｐrofｅssiｏnalsｔothisｎewdｏsingreｇimｅnandalsowaｒnｉｎgａboutthepｏtｅntialforsｅvｅrｅdruginｔerａctionｓwhenpａt(yī)ieｎtstakecolcｈicｉｎe．ＴhemedicｉnalvalueofusｉｎgcolcｈicuｍwasｆirstidｅｎtｉfｉｅdintｈｅfiｒstｃentuｒｙＡ。D.anditsusefoｒtreatingacutegouｔdａt(yī)esbａcｋtｏ1８10．Pｈysiciaｎshaveｐrｅｓｃriｂeｄｔｈemeｄicatiｏｎsｉｎcｅtｈen。Althougｈsｉｎglｅ-iｎgredｉentcolｃhiｃinｅhasnotbeｅnaｐproveｄbｙｔｈeＦDAuｎtilnoｗ,ａcｏmbinａductｃonｔainingcolｃhicineandanagenｔtｈａt(yī)ｉncreasedthｅexcｒetionｏfuriｃaｃｉdintheurｉnewasａpｐrｏvｅdbyｔheFＤＡin1939。FMFｉsthｅｍostｃomｍonｏfthehereditａrｙperiｏdicfｅversyndｒomｅsａndischａracteｒizedbyrecurrｅntｅｐisodｅｓoffevｅr,ａrthｒitisandpaiｎfulinｆlammａt(yī)iｏnofthelininglaｙersofｔheｌungsａnｄabdｏmen.TｈougｈrarｅｉntheUnｉtedＳtates，itismｏrecommoninＭediｔｅrrａnｅancouｎtries.ＰhysicianshaveｐｒesｃribedcｏlchiｃiｎefｏrＦＭFformａnyyeaｒsbaｓedonstｕdiesｓhｏｗｉnｇｔhatｉｔreｄucedthｅｆrｅquencyofattacｋsｂutuｓeoｆcoｌｃhiciｎefｏrFＭＦhａdｎｅverｂeenappｒovｅd.Wiｔｈthｉsａpｐrｏval,ColcrｙsbeｃomesthefiｒｓｔdrｕgａpproｖeｄtｏｔｒeatFMF．CoｌｃrysismａnuｆａｃtｕｒedbyＭutｕａlPharmaceuticaｌCompany，Inc.，Philadeｌｐhｉa。（）美國FDA批準2009－20１0年季節(jié)性流感疫苗FDAApｐrovesVaｃcinefor20０9－20１0SeａsｏnalInfluenza（Jｕly2０,2０0９)TheU。S.ＦooｄandDｒuｇAdｍinistｒaｔiｏnｔodayannｏｕncedthatitｈasａｐprovｅｄａvaｃｃｉneｆoｒ２009－２0１０ｓeasonaｌiｎｆlueｎzaintｈeＵnitedSｔateｓ。Tｈeseａsonaliｎfｌuｅｎｚavａcｃineｗiｌｌｎotprotecｔagａinsttｈe２００9H１N1iｎfｌｕeｎｚaviｒｕsｔｈａt(yī)resultedintｈedeclaratiｏnofaｐaｎｄemicbｙｔhｅWorldHealｔhOrganｉzaｔion(WHO）onJuｎe11,2009．TheFDAcontｉnuｅｓtｏｗorkwiｔｈmanuｆacturｅrs,internａt(yī)ionａlpartｎeｒsanｄotｈergovernmｅntaｇenciestofａciliｔａｔｅtheavailabiｌityofasａfeandeｆfｅctivｅvaccineaｇaｉｎsｔｔhｅ2０09H1Ｎ1influenzavirus.Alｔｈouｇhtｈisyear’ｓsｅaｓｏnａｌvａcｃｉnｅisdiｒectedagａinstotherstｒaｉnsoｆｉnflueｎzaeｘpｅctｅdtobecirculatｉngａnｄwｉllnotｐrovideprｏtｅｃtiｏnａgainsｔｔhｅ2009Ｈ１N1iｎｆlｕenzavｉrus，ｉtiｓstillｉmporｔantforthｏseＡｍericansforwhomitisｒeｃｏmｍendeｄtoreｃeiveｔheseaｓｏnalｉnfluenzavａｃcinｅ．Noｖａccｉneiｓ100percenｔefｆectiｖeagainstpreｖentingdiｓeａｓｅ,bｕtvacｃiｎatｉonistｈｅbeｓtprotectionａgainsｔiｎflｕｅnzaaｎdcanｐrｅｖeｎtmanyｉlｌnesｓｅｓanddeaths?！癟heaｐprovalｏfthiｓｙeａｒ’ssｅaｓonalinflｕｅnｚaｖａccｉneisaｎexaｍpleｏｆtheＦＤA’ｓｉｍportanｔresｐoｎsｉbiｌitytoasｓuｒetimｅｌyavaiｌabilｉtyｏfvａcｃｉｎｅtoheｌpｐroｔｅｃｔｔhｅheａlｔｈoftheAmeriｃaｎpublｉc,”saiｄMａｒgaｒetA.Ｈａmbｕrｇ,Ｍ.D。,cｏmmissｉonerｏｆfｏodanddrｕgｓ.“Ａnewseａsonalinｆｌuenzavacｃiｎeeａcｈyｅarｉｓacriticａltoolｉnproteｃtingpuｂｌichｅaｌｔh."Thesｉxvaccinｅbｒanｄnａmesandmａnｕfacｔurersare:Ａflurｉa，CSLＬimited；Ｆlｕａriｘ,GｌaｘｏSmｉｔhKlｉｎeBiologicals；FluＬaval,IDＢioｍedicａlCoｒpoｒaｔｉon；Fluviｒｉn，NｏvarｔisVacｃinesａndＤiａgnosｔicsLimited;Ｆluｚoｎｅ，SanｏfiPａsteurInc．;aｎdＦluMist，MedIｍmuneＶaccineｓInｃ.Eacｈyear,experｔｓfromtheＦＤA，ＷＨＯ,ＢasｅdonthosｅforeｃａstｓaｎdoｎthｅreｃommｅｎｄaｔionｓoｆtｈeFDA’sVaccineandRelatedProｄuctsAdvｉｓoryＣommiｔtｅe，tｈeFＤAｄeｔeｒminesｔhｅthｒｅestrａinsｔhaｔmanｕｆacturerssｈouｌｄinｃludeiｎｔｈeirvacｃinesｆoｒｔheU．S.population。Ｔheclｏsｅrtheｍatcｈbｅｔweentｈeｃirculatiｎｇstrainsanｄthesｔrａinsｉnthevaｃcine,ｔｈebettertheprotectionagａiｎstthediseａｓｅ.Thｅvaｃcineforthe200９-2010seasonaｌinfluenzａconｔainｓ:anA/Brisbane/59/２0０7(H1N1）－lｉkevｉrｕsaｎA/Brｉsbane／10／2007（H3N2）—ｌｉkｅviruｓaB/Ｂrisbanｅ／6０／2008-likｅｖirusＴherｅisaｌwayｓapossiｂiｌｉtyｏfaleｓｓｔhanoptimａlmａt(yī)chbｅtweeｎthevirussｔrainｓprｅｄｉｃtｅdtｏcircｕｌatｅａｎdthｅvirｕsstraｉｎstｈateｎｄuｐｃausinｇtheｍoｓtiｌlness。Evenｉftｈevaｃcｉｎeａｎｄtｈecｉrcｕｌatinｇsｔrainsareｎoｔaｎexaｃtmaｔch,tｈeｖacｃineｍａｙrｅduｃetｈesevｅrityoｆtheillnesｓｏrmayheｌppreｖｅｎtiｎfｌuｅnｚa-ｒｅlateｄcomplicａｔｉons.AｃcordingtｏthｅCDC，between5ｐeｒcｅｎtanｄ20pｅｒcentoftheU。S．pｏｐｕlationdevelopsinfluenzaｅacｈyear。Morｅthaｎ２００,0００arehospｉtaliｚｅｄfｒomitscoｍpliｃatiｏｎsandaｂout36,00０peoｐｌedｉe。Ｏlｄｅrpeoｐle,yｏuｎｇcｈiｌｄren,ａndpｅopleｗｉｔｈchｒｏnicｍedicａlconditiｏｎsarｅaｔhigherriskforiｎfluenzａ－rｅlatedｃｏmplicationｓ．Ｖａcciｎaｔiｏnoｆthｅｓegrｏuｐsiscriｔicaｌ．Ａｄdｉtionaｌlｙ，influｅnzaｉmmunizａt(yī)ioｎofhｅalthcarｅpｅrsoｎnelisｉmｐortaｎtinprotｅctiｎgthemａndｏthｅｒｓfromｉnflｕｅｎｚa.（)美國FDA批準阿片類鎮(zhèn)痛藥Ｏnsｏlis用于癌癥患者ＦDAＡpproveｓOｐioidＰainRelieverwｉthＲequｉreｄRｉsｋRedｕctｉoｎPｌａn(July16,2009）TheＵ。S。FoｏdanｄＤrugAｄmｉnistratiｏｎtodａyaｐpｒovedOnsolis，ｍｅdｉｃationｉntendedｆorｃｅｒtainpａｔｉenｔswiｔｈcａncertohelpmａnagｅbreａkｔhroughpａｉn–seveｒeflａresofpainｔhatｂreaｋthｒoｕghreｇuｌarｐａiｎmedication．Onsolisiｓiｎaclaｓsofdrｕgｓthatdelｉverthｅpｏtｅntopiｏidfentanylｔｈｒougｈthemouｔh’smucousｍemｂrａnｅｓ．Oｎsoｌiｓdeｌiversfentanyｌviａａnａbsorbabｌefiｌmthａt(yī)ｓtiｃｋsｔotheinsidｅｏfthecｈeeｋ.Ｔhｅdrｕgisｉndiｃatedforthemaｎａgementｏｆbｒｅakthroｕｇhｐａinｉnpaｔiｅntsｗｉthcaｎｃｅr，ａgeｓ18ａnｄｏｌｄer，wｈoaｌreadyuseｏpｉoidｐaiｎmedｉｃatiｏnaroｕｎdthecloｃkａndwhoｎeedanｄａｒeaｂｌｅtｏsaｆelyｕseｈｉgｈdosesofanadditioｎalｏpioidmedｉcine．Sｕcｈｐatientsａｒeconsidｅredopioidｔoｌeraｎtｂecａｕsｅoftheｉrcurrentｏｐioidmedicａt(yī)ｉonｕｓe．Beｃａusefeｎtanylissubjecttoaｂuseanｄmｉsuse,OnsoliswasapproveｄwithａRiskEvaluatｉｏnａndMitiｇaｔｉonStrategy，orREＭS，whichiｓarequiredpｌanformaｎａｇiｎｇrｉsksassocｉatｅdwiｔhadrｕgｏrｂｉｏｌoｇicａｌprｏduｃｔ．“Onsoliｓcanpｒovideｓtroｎｇpａiｎreｌｉeftopatientswhoaｒｅoｐｉoidtｏleranｔ.Bｕｔｆorpatientｓwhoarenoｔopioidtｏleranｔ,itcａnlｅadtooveｒdoｓe，sudｄｅnｓeriousｂｒeatｈiｎgdiｆｆicｕｌｔiesandｄeath，"saidBoｂRappapｏrt,Ｍ．Ｄ。,ｄirｅctｏｒ,DivisionoｆAnesｔheｓia，AnaｌｇesiaaｎdRheumatｏlogyPｒoｄｕctsiｎtｈeＦDA'sCenterfｏrDｒｕｇEvａlｕaｔionanｄＲesearch（CDER）.“Forｔhisreaｓon，OnｓoｌisｓhouｌdbｅpresｃrｉｂｅdonｌyundertｈesafeguａrdsｐｒovidｅdbｙｔheFDＡ-reｑuｉrｅｄＲEMSandｂyhealthcａreｐｒｏfessioｎaｌsknｏwleｄｇｅableaｂoｕｔＯnsolisandtheusｅoｆpotenｔopioｉｄmedicatｉons．”ＴｈeＦoodaｎdDrｕｇAdministratioｎAmendmenｔsActof2007gaveｔheFDAtｈeaｕthｏritytoreqｕｉreｔhatdｒugｓaｎdｂiｏｌｏｇiｃaｌｐｒodｕctｓｈaｖeaRＥMＳtoenｓuｒethattheｂenefｉtsｏfadruｇorｂｉologｉcalｐroductoutweighitsｒisks.AspａrtofthｅREMＳ，OnｓoｌisｗｉllonlybeａvａilａblｅｔhrouｇhａrestricｔeddistrｉbｕｔｉonprogramｃalleｄthｅFOCUＳprogｒａｍ．Ｕｎｄｅrｔｈisｐｒogｒam，onｌｙthoｓeｐｒescribeｒs，ｐaｔientsanｄpｈarｍaciesregiｓｔeredwitｈthｅｐrogramwillbｅabｌetoｐrescrｉbe,ｄisｐense，andｒｅcｅiveOｎｓolｉs.TheＦOCUSprogｒamwｉllprovidetｒainｉｎgａndｅduｃａｔioｎalmatｅrialstoｐrescｒibersanｄpharｍacypeｒsonｎel，andacounselingcallwillbeplacedｔopaｔｉentsｐrｉorｔoｄispensingｔoensureｔhｅyhavebeｅnadｅquatelyeｄuｃaｔedａbｏuttheapｐroprｉateuseｏfthｅdｒｕg．Ｐrｅscriptｉonorderｓｗiｌｌbeｆilｌｅｄｏnlybyｐａrtｉcipatingpharmacｉｅsthａt(yī)ｓendtｈｅｐrｏductdirecｔlytotｈepatieｎts’hoｍｅs。Onｓoｌｉｓwａsapｐrovedwithａboxeｄｗarninｇ,whichｓtaｔｅsthatthemeｄicatｉonｓhouｌdnotbeuｓedforthｅmanaｇemｅntoｆmigraｉnes,dentalpain，orｐostoperaｔivepaiｎｏrbypaｔieｎtswhouｓｅopiｏiｄｓinｔermittｅnｔly,orｏnａnas—ｎeedeｄbａsｉs.Ｉtalsoｗarnsｔｈattｈｅdｒuｇshoｕldbeｋeptouｔofthereachofcｈildrｅnandsｈouldnotbesuｂsｔｉtutｅｄｆｏrotｈｅrfｅntanylprｏdｕｃｔs．InFebruarｙ,theFDAａnnouｎcedthatitwouldrequｉｒeａREMSfｏraｄifferentcｌassoｆopioidsthatｏfferlong—acｔiｎgandexteｎded—rｅleasemedｉcａｔiｏn.TheFＤAｈasheｌｄaserｉesoｆｍeetｉｎgswithstaｋeｈolders，iｎcluｄinｇａlargeｐublicmeeｔing，anｄalｓoｓｏlｉciｔedwriｔteｎpubｌiccｏmmeｎtstoｈearmoreaboｕthowtoｄeveｌopｔhiｓREMS?！癟heRＥMＳforＯnｓoliswａsspｅciｆicallytailoｒeｄｔoｔhaｔdrugandshouldnｏtbevｉewedasamoｄｅlRＥMSforlonｇ-actiｎgａｎdextenｄeｄ-ｒeleasｅopioｉｄproduｃtｓ，”sａｉｄＤouglasThrｏckmorton，Ｍ。D.,depｕtydｉｒectorofCDＥR。“DevelｏｐｉｎｇｔｈｅcoｍpreｈeｎsｉvｅＲEMＳｆorthesｅoｔherprｏduｃtｓｉsaｃoｍｐｌｅｘundertａking．Wewiｌｌｔakeｔhｅtiｍeｎecessａrytoｒevieｗallｏfｔｈepubliccｏｍmentsaｎdwillproｃｅeｄiｎaｄeliberａt(yī)eｍａnｎertｏwardthｅｍutuａlgoalsofｐatientaccessaｎdpａｔeｃtiｏn．”ＯnｓolｉｓiｓｍanufacturedbｙAvｅvaDrugＤeliverｙSystems，Miramａr,Fla。,aｎdmarkｅtｅdundｅrlicenseｆromBi